Treatment of deep vein thrombosis in patients with pulmonary embolism: subgroup analysis on the efficacy and safety of certoparin vs. unfractionated heparin.

The objective of this subgroup analysis of the pivotal studies NMH-TH-3 and NMH-TH-4 was to investigate the incidence of recurrent events of venous thromboembolism in patients with acute deep vein thrombosis (DVT) with and without pulmonary embolism treated with subcutaneous fixed-dose low-molecular-weight heparin certoparin or intravenous unfractionated heparin (UFH). To assess whether the efficacy of the two treatments is modified by the presence or absence of pulmonary embolism, a P value for subgroup by treatment interaction was calculated using logistic regression. The rate of recurrent venous thromboembolic events, defined as DVT, pulmonary embolism and death due to pulmonary embolism, was observed over 6 months. After 6 months of follow-up, 6.58% of patients with pulmonary embolism at baseline treated with certoparin (5/76) compared with 11.5% of patients with pulmonary embolism at baseline treated with UFH (7/61) had a venous thromboembolic event [relative risk (RR) = 0.57, confidence interval (CI) = 0.19-1.72]. In the group of patients without pulmonary embolism at baseline, 2.82% of patients treated with certoparin (23/816) and 4.63% of patients treated with UFH (37/800) had a venous thromboembolic event (RR = 0.61, CI = 0.37-1.02). The test for interaction between the groups of patients with and without pulmonary embolism was not significant (P = 0.886). The same was true for the safety results with regard to major bleedings and death. These data suggest that the recommendation for the use of certoparin in the treatment of isolated DVT can safely be extended to treatment of DVT in patients concomitantly suffering from pulmonary embolism.